Global Validation Engineering Lead

West Pharmaceutical Services

Dublin

On-site

EUR 101,000 - 130,000

Full time

14 days+

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Job summary

West Pharmaceutical Services is seeking a Senior Validation Engineer to contribute to the development and implementation of validation strategies across Global Technical Operations. You will lead a globally dispersed team to ensure qualification of equipment, facilities, utilities, automated systems, processes and cleaning procedures in line with GMP and industry standards.

The role requires 10 years of validation engineering experience in a cGMP environment, plus a degree in Computer Science,

Qualifications

Must have a third level qualification to degree level in Computer Science, Engineering or related fields.
Must have 10 years of validation engineering experience in a cGMP regulated industry.
Minimum 10 years post graduate experience in a high-volume manufacturing environment, ideally in Medical Device/Pharmaceutical sectors.
In-depth knowledge of ISO 13485; EU GMP, CFR Part 820.

Responsibilities

Provide technical leadership to a globally dispersed Validation Engineering team across the Global Technical Operations network.
Direct resources to support validation programs and harmonize standards and procedures.
Oversee preparation, review and approval of validation documentation (IQ/OQ/PQ, FAT/SAT).
Lead site validation Master Plans and drive risk-based validation approaches.
Ensure compliance with GMP, quality policy and safety guidelines.